Document from CIS Legislation database © 2003-2020 SojuzPravoInform LLC

The document ceased to be valid since  February 15, 2018 according to article 39 of the Law of the Kyrgyz Republic of  August 2, 2017 No. 165

LAW OF THE KYRGYZ REPUBLIC

of April 30, 2003 No. 91

About medicines

(as amended on 30-12-2015)

Accepted by General Court of Jogorku Kenesh of the Kyrgyz Republic on March 13, 2003

This Law creates the legal basis of activities of subjects of drug circulation, determines powers and responsibility of executive bodies in the sphere of drug circulation, establishes single requirements to the treatment of medicines in the Kyrgyz Republic.

Chapter I. General provisions

Article 1. Subject of regulation of this Law

This Law governs the relations arising in connection with development, production, production, preclinical and clinical trials of medicines, control of their quality, efficiency, safety, trade in medicines and other actions in the sphere of drug circulation.

This Law establishes priority of the state production control, production, storage, efficiency, quality and safety of medicines.

Article 2. Coverage of this Law

This Law is applied to the relations arising in the sphere of drug circulation in the territory of the Kyrgyz Republic if the legislation of the Kyrgyz Republic does not establish other.

Article 3. Legislation of the Kyrgyz Republic on medicines

The legislation of the Kyrgyz Republic on medicines consists of this Law, other laws and other regulatory legal acts of the Kyrgyz Republic.

Features of the address of narcotic medicines and psychotropic substances are regulated by the laws of the Kyrgyz Republic.

If the international treaty of the Kyrgyz Republic establishes other rules than provided by this Law, then rules of the international treaty are applied.

Article 4. The basic concepts used in this Law

Pharmaceutical institution - pharmaceutical warehouses, drugstores, drugstores of healthcare institutions, pharmaceutical Items, pharmaceutical booths, shops of medical equipment and-point optics.

Safety of medicines - the characteristic of risk degree of damnification to health and negative influence of medicines on human body.

Bioavailability - relative amount of medicine which reaches system blood-groove (extent of absorption), and the speed to which this process happens (absorption speed).

Biologically active nutritional supplements - the products containing the vitamins, mineral and other substances of natural origin promoting maintenance of health and prevention of diseases.

Bioequivalence - identical bioavailability of generic and original medicines.

Generic medicine - the reproduced medicine which is containing the same active ingredient in the same dose and dosage form and having the same action, as original medicine arrived in the address after expiration of patent protection on active agent.

The generic name - the international non-proprietary name (INPN) appropriated by the World Health Organization (WHO) to active agent, held for use as public property without any restrictions as nobody can be the owner of the rights to its application.

Homeopathic medicines - one - or the multicomponent medicines containing, as a rule, the microdoses of active connections which are made on special technology and intended for application in the form of various dosage forms.

The state pharmacopeia - the collection of pharmakopeyny Articles.

Before creation of the State pharmacopeia of the Kyrgyz Republic in the territory of the Kyrgyz Republic are applied: State pharmacopeia of the USSR IX, X, XI editions, International pharmacopeia, pharmacopeias of the USA (USP) and Germany (DAB), European pharmacopeia (ER), British pharmacopeia (BP).

The state register of medicines - the official document containing list of the medicines registered and allowed for use in medical practice.

Production of medicines - production of medicines in pharmaceutical institution according to recipes of doctors on the basis of the medicines registered in the Kyrgyz Republic.

Use of medicines - complex of the actions directed to bringing medicine to the consumer.

Quality of medicine - set of the properties giving to medicine capability to satisfy consumers according to the appointment and to meet the requirements established by the regulating document.

Clinical testing of medicines - researches of medicines on the person (patients and volunteers) for the purpose of studying of their pharmakodinamika and pharmacokinetics, efficiency and safety, bioequivalence and bioavailability.

Medicines - the dosed medicines ready to application.

Medicines - the substances, mix of substances applied to prevention, diagnostics, treatments of disease, prevention of pregnancy received from blood and its components, and also bodies, tissues of the person or animal, plants, minerals by methods of synthesis or using biological technologies. Substances, substances of vegetable, animal or synthetic origin having pharmacological activity and also the auxiliary materials intended for production and production of medicines belong to medicines; also biologically active nutritional supplements, homeopathic medicines, the products of medical appointment used for diagnostics, correction, rehabilitation, change of condition and function of organism, prevention and treatment of diseases, means and objects of patient care, chemical reactants, reagents, X-ray contrast substances and test systems belong to medicines.

Dosage form - the form, convenient for practical application, given to medicines.

Medical immunobiological supplies - the medicines intended for immunological prevention and immunological therapy and diagnosis of infectious and noninfectious diseases and allergic conditions. Vaccines, anatoksina, bacteriophages, eubiotik, immunoglobulins, serums, diagnostic medicines, allergens, nutrient mediums belong to medical immunobiological supplies.

Narcotic medicines - the medicines causing mental and physical dependence, included in the list of drugs constituted and updated according to the Single convention on drugs of 1961 and the legislation of the Kyrgyz Republic.

Substandard medicines - the medicines not suitable for application owing to discrepancy to the requirements established by the regulating document.

The regulating document - the document establishing standards, rules, regulations, instructions, specifications, production schedules, characteristics concerning different types of activities in the sphere of drug circulation.

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